Recall Z-2640-2026 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
| Date | Jul 1, 2026 (initiated Jun 16, 2026) |
| Status | Open, Classified |
| Reason | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing. |
| Root cause | Software design |
| Action | Accuray issued am Urgent Field Safety Notice to it consignees via hand delivered letter on 6/16/2026. The notice explained the issue, potential risk to health and provided the following safety instructions: "This condition may occur during collimator housing drop off or pick up while the collimator housing is positioned over the Xchange table. The system will interlock, stop motion, and display a message at the operator console to contact service. If an interlock occurs: (1) remove the patient from the treatment room before troubleshooting, (2) do not initiate treatment robot motion from t |
| Quantity | 48 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, Ukraine. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170788 | CyberKnife Treatment Delivery System Accuray Incorportaed, Apr 11, 2017 |